Assessment of Thai Medical Device Manufacturers' Readiness for Thailand's Membership in the International Medical Device Regulators Forum

Abstract

Background: The global medical device industry is experiencing rapid growth, with a projected market value of USD 1,209.42 billion by 2035. Thailand's "Thailand Medical Hub" strategy had positioned the country as a major regional manufacturer and exporter. To address increasingly stringent international standards, the Thai Food and Drug Administration (Thai FDA) planned to apply for membership in the International Medical Device Regulators Forum (IMDRF), a global network spanning six continents. Membership requires aligning regulatory systems with IMDRF and Global Harmonization Task Force (GHTF) technical documents throughout the product life cycle. Assessing the readiness of Thai manufacturers is therefore essential to identifying gaps and obstacles in elevating national standards to an international level.

Objectives: To analyze the regulatory gaps between IMDRF standards and Thailand’s current system, and to evaluate the readiness and feedback of Thai medical device manufacturers regarding Thailand's IMDRF membership application to guide future regulatory development.

Methods: This qualitative study in Regulatory Science utilized literature reviews of relevant laws and regulations, alongside in-depth interviews with seven medical device manufacturers from the Medical Device Manufacturers Industry Group, Federation of Thai Industries. Stratified purposeful sampling was employed to cover both Non-In Vitro Diagnostic (Non-IVD) and In Vitro Diagnostic (IVD) devices across various risk levels. Interview topics focused on IMDRF/GHTF Conformity Assessment principles, with the study conducted from December 2025 to February 2026.

Results: The gap analysis revealed that while Thailand’s regulations align with the ASEAN Medical Device Directive (AMDD), gaps remain compared to IMDRF, particularly regarding the rigor of unique device identification (UDI), personalized medical device, and post-market clinical follow-up study. Regarding readiness, most manufacturers lacked prior knowledge of IMDRF but were familiar with AMDD. All participants maintained ISO 13485 quality management systems and adverse event reporting mechanisms consistent with IMDRF principles. However, concerns were raised regarding increased operational costs and documentation complexity, especially among SMEs.

Conclusions: Thailand’s application for IMDRF membership does not present a major structural obstacle for manufacturers, as the existing regulatory framework already aligns with AMDD, which is rooted in IMDRF technical documents. Nevertheless, the government should establish a clear Roadmap and provide support in terms of knowledge and funding to mitigate the burden on small and medium-sized enterprises.